Efficacy of Liposomal Bupivacaine Post Septorhinoplasty

NCT ID: NCT05964868

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2027-07-31

Brief Summary

The objective of this study is to determine if there is a difference in post-operative pain after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia compared to other standard local anesthetic regimens.

Detailed Description

Hypothesis: Patients receiving postoperative liposomal bupivacaine (EXPAREL®) at the surgical site after their septorhinoplasty will have better postoperative pain control and require fewer narcotics by means of a lower MME compared to the placebo group and the group that receives postoperative 0.25% bupivacaine with 1:200,000 epinephrine.

This a prospective randomized controlled, single-blind study evaluating the efficacy of EXPAREL® versus plain bupivacaine HCl and placebo after perinasal injections during septorhinoplasty procedures. Seventy-two total patients undergoing septorhinoplasty will be randomly distributed into three groups (20 patients per group) with various postoperative local anesthesia regimens. All groups will be given standard oral postoperative pain regimens as prescribed by the primary surgeon, typically consisting of alternating doses of 1000 mg acetaminophen and 800 mg ibuprofen with oxycodone 5 mg every 6 hours as needed for breakthrough pain. All three groups will receive the same treatment at the beginning of surgery with pre-incisional local surgical site injections with perinasal blocks of 1% lidocaine with 1:100,000 epinephrine. Group one (study group) will receive a five mL injection of EXPAREL® postoperatively, group two will receive a five mL injection of 0.25% bupivacaine with 1:200,000 epinephrine postoperatively, and group three will receive a five mL injection of saline along the surgical site, all in a ring block fashion (see illustration). This ring block involves nerve blocks to nasal branches of the supratrochlear, infraorbital, and infratrochlear nerves. This will also be injected into the floor of the nasal cavity to block branches of the nasopalatine nerve. The remainder of the ring block targets local infiltration surrounding the nose and injections are over bone. Although there is a potential risk of diffusion to adjacent cartilage, this risk is predicted to be low. Their use of postoperative pain medications will then be documented in the immediate postoperative period in the post-anesthesia care unit (PACU) as well as the following week postoperatively, every day, for three times a day. All groups will be required to fill electronic pain journals through RedCap (a HIPPA compliant server) to record consumption of pain medications and pain levels as reported by visual analog pain scales, the Wong-Baker FACES pain rating scale, and modified McGill pain questionnaire, all of which are validated tools for pain assessment. Patients will be subsequently followed over the course of six months postoperatively with these validated measures, use of pain medication, and by clinical exam of the nose/injection site including both external and internal nasal exam, palpation of the nose and cartilage grafts, evaluation static and dynamic function of the nose, and the presence of any adverse outcomes including but not limited to cartilage graft loss, septal perforation, synechiae formation, infection, and persistent or worsening nasal obstruction.

Conditions

Rhinoplasty; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Liposomal Bupivacaine

This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.

Group Type: EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type: DRUG

Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.

Bupivacaine with epinephrine

This group will receive a one-time 5 mL injection of 0.25% bupivacaine with 1:200,000 epinephrine post-operatively at the surgical site.

Group Type: ACTIVE_COMPARATOR

0.25% bupivacaine with 1:200,000 epinephrine

Intervention Type: DRUG

Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.

Saline solution

This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

Group Type: PLACEBO_COMPARATOR

Placebo - Saline solution

Intervention Type: OTHER

This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

Interventions

Liposomal Bupivacaine

Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.

Intervention Type: DRUG

0.25% bupivacaine with 1:200,000 epinephrine

Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.

Intervention Type: DRUG

Placebo - Saline solution

This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subject must be undergoing rhinoplasty or septorhinoplasty surgery

2. Male or female subjects greater than or equal to 18 years of age

3. Written informed consent must be obtained

Exclusion Criteria

2. The subject is a pregnant or lactating 3. Patients have a cognitive impairment 4. Patient is a prisoner 5. Patients with hypersensitivity to local anesthetics and pain medications used in the study 6. Patients weighing less than 48 kg 7. Patients preoperatively taking narcotics for chronic pain 8. Patients with pre-existing painful conditions (complex regional pain syndrome, fibromyalgia, neuropathy) 9. Patients with liver dysfunction 10. Patients with increased creatinine (over 1.5 mg/dl) 11. Patients who have undergone autologous costal cartilage grafting with their rhinoplasty 12. Morbid obesity (BMI >40)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jessyka Lighthall

OTHER

Sponsor Role: lead

Responsible Party

Jessyka Lighthall

Chief, Division of Facial Plastic & Reconstructive Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jessyka Lighthall, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Health

Locations

Jessyka Lighthall

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00020710

Identifier Type: -

Identifier Source: org_study_id